Flunitrazepam の舌下投与法による鎮静法の臨床的研究

Abstract

Psychosedation is the most desirable accessory treatment for a patient with dentalphobia and/or systematic complications. It enables a patient to be treated without the tention assosiated with tranquilizers which produce an excited state of the autonomic nervous system. Intravenous injection of benzodiazepine is a superior method with a steady effect ; However, it cannot be adopted for a patient with a phobia of the injection needle. Accordingly, sublingual administration of flunitrazepam (FNZP) was examined as a new method for sedation. Seventeen healthy male volunteers with an average age of 24.8 years were administered 1.5 mg (0.75ml) of FNZP sublingually. The degree of sedation and disturbances of respiratory, circulatory and mental function were measured. Nine of the 17 cases were monitored just before the medication, and 30 and 120 minutes after administration (Group F1). The remaining 8 cases were monitored just before the medication, and 60 minutes and 180 minutes after medication (Group F2). Extra five healthy male volunteers with an average age of 21.5 years were given 0.75ml of normal saline solution sublingually as controls (Group C) and observed at the same points as Group F (Group F1 plus Group F2). The results obtained were as follows : 1. Conscious levels were between I and II-20 by Ohta's 3-3-9 classification during the entire time course in all cases of Group F. Group F appeared to be in mild sedation from 30 to 120 minutes after the administration. Desirable amnesia was obserbed between 30 and 60 minutes after the administration. 2. Paco_2, HCO^-_3 and Base Exess increased remarkablly 60 minutes after the administration of FNZP. However, all changes were within normal ranges. 3. Systolic blood pressure, pulse rate, and probably rate pressure product decreased in both Group F and Group C. On the other hand, diastolic blood pressure showed a tendency to increase in Group C in contrast to a tendency to decrease in Group F. Statistical defferences were observed between the two groups at each point of the time course. 4. Times required for the caliculation and key sellection were prolonged until 180 minutes after the administration. The effects were greatest at 30 and 60 minutes after the administration. In conclusion, this study has demonstrated that 1.5mg of FNZP given sublingually produces mild sedation between 30 and 60 minutes after the administration with no particular respirocirculatory and mental complication.